NCT05187858已完成1 期
A Phase I Open-Label Study of LNP3794 (BI3011441) in Subjects With NRAS/KRAS Mutated Advanced or Metastatic Refractory Solid Tumors
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Lupin Ltd.
- 入组人数
- 15
- 试验地点
- 4
- 主要终点
- Number of subjects with dose limiting toxicities (DLTs) at each dose level during the first cycle
研究概览
简要总结
This is a Phase I, open-label, dose escalation study of LNP3794 (BI3011441) in subjects with NRAS/KRAS mutated advanced or metastatic refractory solid tumors. The purpose of this study is to evaluate the safety/tolerability, pharmacokinetic and pharmacodynamic profile of the orally administered LNP3794 (BI3011441) as monotherapy at selected dose levels.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects ≥18 years of age
- •Pathologically documented, locally-advanced or metastatic solid malignancy with NRAS or KRAS mutation
- •At least one target lesion that can be measured per RECIST version 1.1
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- •Adequate organ function (bone marrow, hepatic, renal, cardiovascular)
- •Documented disease progression despite appropriate prior standard therapies or subjects for whom no standard therapy exists for their tumor type and disease stage
- •Reproductive criteria (as defined in the protocol)
排除标准
- •Subjects with symptomatic central nervous system (CNS) metastases
- •History of another primary malignancy, with the exception of locally excised nonmelanoma skin cancer and carcinoma in situ of uterine cervix
- •Known active hepatitis B infection or hepatitis C infection
- •Known pre-existing interstitial lung disease
- •Known diagnosis of human immunodeficiency virus (HIV) infection
- •History or current evidence/risk of retinal vein occlusion (RVO) or central serous retinopathy; or known risk factors for RVO or central serous retinopathy
- •Any severe and/or uncontrolled medical conditions or other conditions that, in the opinion of the Investigator, Sponsor, or contract research organization, could affect the subject's participation in the study
- •Impaired cardiac function or clinically significant cardiac diseases
- •Previous treatment with RAS or MEK targeting agents
- •Chemotherapy, biologic therapy, immunotherapy, radiotherapy, or investigational agents within 5 half-lives or within 4 weeks (whichever is longer) prior to administration of the first dose of study treatment
研究组 & 干预措施
LNP3794
Experimental
Participants will receive LNP3794 orally once daily at different doses in 28 day cycles on a continuous basis
干预措施: LNP3794 (Drug)
结局指标
主要结局
Number of subjects with dose limiting toxicities (DLTs) at each dose level during the first cycle
时间窗: up to Day 28
Dose limiting toxicities will be evaluated through the first cycle (each cycle is 28 days)
次要结局
- Maximum Plasma Concentration (Cmax) of LNP3794(Cycle 1 (each cycle is 28 days) Day 1 and Day 14)
- Area under the concentration-time curve from time zero to the end of dosing interval (AUC[0-tau])(Cycle 1 (each cycle is 28 days) Day 1 to 2 and Day 14 to 15)
- Time to maximum concentration (Tmax)(Cycle 1 (each cycle is 28 days) Day 1 and Day 14)
- Number of subjects with DLTs during the entire on-treatment period(up to 2 years)
- Number of subjects with Grade ≥3 treatment-related adverse events (AEs)(up to 2 years)
- Number of subjects with treatment-related AEs at each dose level(up to 2 years)
- Area under the concentration-time curve from time zero to the time of last quantifiable concentration (AUC[0-last])(Cycle 1 (each cycle is 28 days) Day 1 and Day 14)
研究者
研究点 (4)
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